kyocera.comInitia Total Hip System & BIOCERAM AZUL(R) HEAD
KYOCERA Medical Corporation
KYOCERA Medical Corporation
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012425419 | 3010566635 | KYOCERA Medical Corporation | 1 | N | 2026-01-01 | 6 Takeda Tobadono-cho, Fushimi-ku Kyoto JP 612-8450 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 04580810059420 | BIOCERAM AZUL HEAD - """AZUL HEAD 22 +0Size: φ22MM O.D.Offset: +0mmTaper: 12/14""" | 909-557-2360 | kmti.info@kyocera.com |
| 04580810059437 | BIOCERAM AZUL HEAD - """AZUL HEAD 22 +3Size: φ22MM O.D.Offset: +3mmTaper: 12/14""" | 909-557-2360 | kmti.info@kyocera.com |
| 04580810059444 | BIOCERAM AZUL HEAD - """AZUL HEAD 26 +0Size: φ26MM O.D.Offset: +0mmTaper: 12/14""" | 909-557-2360 | kmti.info@kyocera.com |
| 04580810059451 | BIOCERAM AZUL HEAD - """AZUL HEAD 26 +3.5Size: φ26MM O.D.Offset: +3.5mmTaper: 12/14""" | 909-557-2360 | kmti.info@kyocera.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 203577 | 1018706057 | K243444 | BIOCERAM AZUL® HEAD | LZO | 2024-12-05 |
| 203577 | 1369568277 | K160895 | Initia Total Hip System & BIOCERAM AZUL(R) HEAD | LZO | 2016-11-01 |
| 203577 | 1543586752 | K160895 | Initia Total Hip System & BIOCERAM AZUL(R) HEAD | LZO | 2016-11-01 |
| 203577 | 1170204229 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LZO | 3 | 2024-12-05 |
PMN#
GUDID#
BIOCERAM AZUL HEAD - """AZUL HEAD 22 +0Size: φ22MM O.D.Offset: +0mmTaper: 12/14"""
2026-02-27
BIOCERAM AZUL HEAD - """AZUL HEAD 22 +3Size: φ22MM O.D.Offset: +3mmTaper: 12/14"""
2026-02-27
BIOCERAM AZUL HEAD - """AZUL HEAD 26 +0Size: φ26MM O.D.Offset: +0mmTaper: 12/14"""
2026-02-27
BIOCERAM AZUL HEAD - """AZUL HEAD 26 +3.5Size: φ26MM O.D.Offset: +3.5mmTaper: 12/14"""
2026-02-27
BIOCERAM AZUL HEAD - """AZUL HEAD 28 +7Size: φ28MM O.D.Offset: +7mmTaper: 12/14"""
2026-02-27
Initia Total Hip System - """OFFSET SHELL INSERTER TRAY"""
2026-02-27
Initia Total Hip System - """INITIA INTERMEDIATE SIZE BROACH CASE"""
2026-02-27
Initia Total Hip System - """STARTING REAMER 5182"""
2026-02-27
Initia Total Hip System - """OFFSET SHELL INSERTER"""
2026-02-27
Initia Total Hip System - """VERSION GUIDE SUPINE LEFT"""
2026-02-27
Initia Total Hip System - """VERSION GUIDE SUPINE RIGHT"""
2026-02-27
Initia Total Hip System - """INITIA BROACH 1.5Size: #1.5"""
2026-02-27
Initia Total Hip System - """INITIA BROACH 2.5Size: #2.5"""
2026-02-27
Initia Total Hip System - """INITIA BROACH 3.5Size: #3.5"""
2026-02-27
Initia Total Hip System - """INITIA BROACH 4.5Size: #4.5"""
2026-02-27
Initia Total Hip System - """INITIA BROACH 5.5Size: #5.5"""
2026-02-27
Initia Total Hip System - """LINER INSERTER 44Size: 44mm"""
2026-02-27
Initia Total Hip System - """12/14 FEMORAL HEAD TRIAL 44 -3.5Outer Diameter: 44mmOffset: -3.5mm"""
2026-02-27
Initia Total Hip System - """12/14 FEMORAL HEAD TRIAL 44 +0Outer Diameter: 44mmOffset: +0mm"""
2026-02-27
Initia Total Hip System - """12/14 FEMORAL HEAD TRIAL 44 +3.5Outer Diameter: 44mmOffset: +3.5mm"""
2026-02-27
Initia Total Hip System - """12/14 FEMORAL HEAD TRIAL 44 +7Outer Diameter: 44mmOffset: +7mm"""
2026-02-27
Initia Total Hip System - """STD LINER TRIAL 44-66/68/70 Type: FlatInner Diameter: 44mmOuter Diameter: 66/68/70mm"""
2026-02-27
Initia Total Hip System - """STD LINER TRIAL 44-72/74 Type: FlatInner Diameter: 44mmOuter Diameter: 72/74mm"""
2026-02-27
Initia Total Hip System - """MX LINER TRIAL 44-66/68/70 Type: ElevatedInner Diameter: 44mmOuter Diameter: 66/68/70mm"""
2026-02-27
Initia Total Hip System - """MX LINER TRIAL 44-72/74 Type: ElevatedInner Diameter: 44mmOuter Diameter: 72/74mm"""
2026-02-27
Initia Total Hip System - """STD-HO LINER TRIAL 32-46Type: Flat, HOInner Diameter: 32mmOuter Diameter: 46mm"""
2026-02-27
Initia Total Hip System - """STD-HO LINER TRIAL 28-48Type: Flat, HOInner Diameter: 28mmOuter Diameter: 48mm"""
2026-02-27
Initia Total Hip System - """STD-HO LINER TRIAL 32-48Type: Flat, HOInner Diameter: 32mmOuter Diameter: 48mm"""
2026-02-27
Initia Total Hip System - """STD-HO LINER TRIAL 28-50Type: Flat, HOInner Diameter: 28mmOuter Diameter: 50mm"""
2026-02-27
Initia Total Hip System - """STD-HO LINER TRIAL 32-50Type: Flat, HOInner Diameter: 32mmOuter Diameter: 50mm"""
2026-02-27
Initia Total Hip System - """STD-HO LINER TRIAL 36-50Type: Flat, HOInner Diameter: 36mmOuter Diameter: 50mm"""
2026-02-27
Initia Total Hip System - """STD-HO LINER TRIAL 32-52/54Type: Flat, HOInner Diameter: 32mmOuter Diameter: 52/54mm"""
2026-02-27
Initia Total Hip System - """STD-HO LINER TRIAL 36-52/54Type: Flat, HOInner Diameter: 36mmOuter Diameter: 52/54mm"""
2026-02-27
Initia Total Hip System - """STD-HO LINER TRIAL 32-56/58Type: Flat, HOInner Diameter: 32mmOuter Diameter: 56/58mm"""
2026-02-27
Initia Total Hip System - """STD-HO LINER TRIAL 36-56/58Type: Flat, HOInner Diameter: 36mmOuter Diameter: 56/58mm"""
2026-02-27
Initia Total Hip System - """STD-HO LINER TRIAL 40-56/58Type: Flat, HOInner Diameter: 40mmOuter Diameter: 56/58mm"""
2026-02-27
Initia Total Hip System - """STD-HO LINER TRIAL 32-60/62/64Type: Flat, HOInner Diameter: 32mmOuter Diameter: 60/62/64mm"""
2026-02-27
Initia Total Hip System - """STD-HO LINER TRIAL 36-60/62/64Type: Flat, HOInner Diameter: 36mmOuter Diameter: 60/62/64mm"""
2026-02-27
Initia Total Hip System - """STD-HO LINER TRIAL 40-60/62/64Type: Flat, HOInner Diameter: 40mmOuter Diameter: 60/62/64mm"""
2026-02-27
Initia Total Hip System - """STD-HO LINER TRIAL 32-66/68/70Type: Flat, HOInner Diameter: 32mmOuter Diameter: 66/68/70mm"""
2026-02-27